Transverse Cavity Device and Method

ABSTRACT

A surgical instrument and method is provided for creating and preparing a cavity in a bony intervertebral body. Asymmetical cutting structures selectively open a cavity which has a relatively large surface area in the vertical direction. One method pertains to the treatment of a vertebral compression fracture.

CROSS-REFERENCE TO RELATED CASES

The present case claims the benefit of, and incorporates by referencethe following U.S. provisional applications:

U.S. Provisional Patent Application Ser. No. 60/227,050 filed Aug. 21,2000, entitled “Vertebroplasty Cavity Creation using an Expanding Tube”and, U.S. Provisional Patent Application Ser. No. 60/225,191 filed Aug.14, 2000, entitled “Vertebral Body Expander.”

FIELD OF THE INVENTION

The present invention relates generally to the treatment of compressionfractures in bones, and more specifically to a device and a method forcutting a “transverse” cavity in the bone as one part of a therapy.

BACKGROUND OF THE INVENTION

The human spine consists of a complex set of interrelated anatomicelements including a set of bones called vertebral bodies.Intervertebral discs separate most vertebral bodies. These discsincludes a “spongy” nucleus pulpous surrounded by an annulus fibrosis“membrane.” The annulus fibrosis connects the opposed endplates ofadjacent vertebral bodies. All of these structures together with musclesact to provide motion, stability and protection for the spinal cord.When healthy, these structures effectively protect the spinal cord andallow for normal motion.

However, there are many disease states and aging processes that impactthe patient. Osteoporosis and metastatic disease reduce the structuralintegrity of the vertebral bodies, predisposing them to fracture.Vertebral fractures can lead to loss of vertebral height, which canexacerbate existing neurological conditions or predispose the spine toother symptoms. Back pain often results from these conditions.

Vertebroplasty is an effort to stabilize these fractures and toalleviate this source of pain. Generally, if not treated, fractures andloss of height result in a cascade of injury which is undesirable. Forthis reason, various efforts have been directed at stabilizing andrestoring the natural vertebral bodies of the back.

Many surgeon experts suggest that it is desirable to intervene andrestore the height of the vertebral body and natural biomechanics of thespine, in addition to stabilizing the spine to provide pain relief. Asan initial step to fracture reduction, which for vertebral compressionfractures restores anatomic vertebral height it may be desirable to cuta cavity that is approximately transverse to the vertical axis of thevertebral body. This cavity is intended to create a large, uniform,initial surface area for fracture reduction devices. The transversecavity reduces contact stress in supporting bone and decreases thelikelihood of cancellous compaction associated with prior arttechniques. Thus, this step increases the likelihood that the fracturewill be reduced rather than simply creating a large cavity within a bonystructure. In general, it may be desirable to locate this transversecavity near the fracture, which is generally located in the anteriorportion of the vertebral body. It is important to create a shallowcavity at the correct location to minimize disruption of cancellous boneand to facilitate further therapeutic intervention.

The presently available techniques and devices expand along a path ofleast resistance within the cancellous bone. As a result, these devicesdo not expand in a predictable manner, often expanding vertically beforeexpanding horizontally (transverse). Rather than consistently reducingthe fracture, these techniques often crush the cancellous bone, creatingan expanded cavity without necessarily reducing the fracture orrestoring the natural anatomy.

Another reason for creating a narrow cavity is to impart known fracturezones in the bone. These fracture zones enable controlled movement ofthe bone during other therapeutic procedures. These fracture zones alsocreate flow channels for various injectable materials that may be usedin a further therapeutic intervention.

SUMMARY

In contrast to the prior art the devices and methods of the presentinvention are used to create an initial cavity in the vertebral bodythat has a controlled shape and location. FIG. 13 represents a prior artprocedure where a narrow and small cavity 17 is filled with a balloonand the overall “footprint” is small so that the total distraction forceis also small. FIG. 14 represents a cavity created according to theinvention filled with a balloon to apply distraction force. In thisfigure, the increased area of the “footprint” of the transverse cavity18 permits greater distraction force per unit balloon pressure.

The vertebral body is entered through either a transpedicular orextrapedicular location with a needle, trocar or other access devices.The cavity creation tool of the invention is inserted into thecancellous bone of the vertebral body through the relatively small areaaperture created by the trocar or needle. The cavity creation toot isthen activated and manipulated.

In general, the tool is directed to a site near the bone fracture. Inthe context of a vertebral compression fracture, the fracture istypically located in the anterior portion of the vertebral body. Oncepositioned at the desired site, the device is used to create a cavity.Although several related embodiments of the cavity creation tool arecontemplated and illustrated, each of them defines a cutting or shearingplane. Each device limits its action to a controlled area of the bone.The controlled area both defines and is a portion of the “transverse”cavity.

Once the preferred transverse cavity is created, any number ofinterventions can be performed. For example, a device that “expands” maybe introduced to reduce the fracture. Typically, the reduction isintended to restore the normal anatomy. This expansion device may beremoved or permanently implanted.

Once a fracture is reduced, the bone cavity may be filled with a bonefiller material such as bone cement, allograft, or synthetic bonesubstitutes. The filler acts to increase the stability and strength ofthe bone. In some interventions, the filler may be combined with bonegrowth factors (BMPs, cell therapy, autologous growth factors) toaccelerate bone remolding and increase the amount of bone remodeling.Likewise, other drugs or therapies (including but not limited toantibiotics, chemotherapy, and other drug therapies) may be combinedwith the bone filler.

Although the invention is illustrated within the vertebral bodycompression fracture treatment context, other secondary interventions oroperations can be contemplated for using the shaped cavity.

Although the invention is particularly useful for the treatment ofvertebral bodies, it should be understood that similar bone fracturegeometries exist in other parts of the body. For this reason, thedevices and methods of the invention may be used in the treatment of anycompaction fracture, such as but not limited to the tibial plateaufractures, distal radius fractures, calcaneous, distal tibial fractures,and humeral fractures.

BRIEF DESCRIPTION OF THE DRAWINGS

Illustrative embodiments of the inventions are shown throughout theseveral views of the drawings. For ease of illustration, the inventionsare disclosed in the context of the repair of a vertebral body, howeverthe device and method can be applied in other compression fractureapplications including, but not limited to tibial plateau, distalradius, calcaneotis, distal tibial fractures, and humeral fractures.

In these illustrative but not limiting drawings, like reference numeralsindicate equivalent structure, wherein:

FIG. 1 is a phantom view of a vertebral body showing a transversecavity, certain tool features and a coordinate system;

FIG. 2 is a cross section of a vertebral body illustrating a portion ofa cavity creation tool;

FIG. 3 is a cross section of a vertebral body illustrating a portion ofa cavity creation tool;

FIG. 4 is a cross section of a portion of a cavity creation tool;

FIG. 5 is a cross section of a portion of a cavity creation tool;

FIG. 6 is a cross section of a vertebral body illustrating a portion ofa cavity creation tool;

FIG. 7 is a cross section of a vertebral body illustrating a portion ofa cavity creation tool;

FIG. 8 is a cross section of a vertebral body illustrating a portion ofa cavity creation tool;

FIG. 9 is a cross section of a vertebral body illustrating a portion ofa cavity creation tool;

FIG. 10 is a cross section of a vertebral body illustrating a portion ofa cavity creation tool;

FIG. 11 is a cross section of a vertebral body illustrating a portion ofa cavity creation tool;

FIG. 12 is a cross section of a vertebral body illustrating a portion ofa cavity creation tool;

FIG. 13 is a cross section of a vertebral body illustrating a portion ofa hydraulic lifting device of the Prior Art; and,

FIG. 14 is a cross section of a vertebral body illustrating a portion ofa hydraulic lifting device.

DETAILED DESCRIPTION

FIG. 1 is a phantom view of a vertebral body showing a transverse cavity18 and a coordinate system 16. This figure shows a vertebral body 10 inisolation. Two possible surgical entry points into the vertebral bodycontemplated within the scope of the invention are illustrated. Oneentry point is “transpedicular.” This approach is indicated by thephysical location of tube 12, traveling through the pedicle into thevertebral body 10. Another approach is “extra-pedicular.” This accessapproach is illustrated by tool 14 entering the vertebral body at alocation lateral of the transpedicular approach on the posterolateralcorner of the vertebral body.

The typical surgery will include a small incision in the back adjacentto the vertebral body. Next, a small gauge needle or guide-wire isintroduced to confirm proper positioning under fluoroscopy. Physicianstypically utilize an 11-gauge needle for the transpedicular approach anda larger needle or tube (up to 6 mm ID) for the extra-pedicularapproach. Many physicians advance cannulated tools over a small gaugeneedle to successively increase the size of the working channel.

Other physicians may prefer to place a guide catheter at the site and tointroduce tools though the lumen of the guide catheter. In general, thetools described herein can be used either over the wire or through aguide catheter or alone at the election of the physician.

In this figure, a coordinate system 16 identifies a vertical directionZ, which points along the spine. The Y-direction is generally anterior.It is the purpose of the invention to create a cavity with a fixed andcontrolled vertical extent (Z-axis height) and a controlled shape in theX-Y plane. For the purposes of this disclosure, the term transversecavity will be used interchangeably with a cavity created parallel tothe surface that is to be reduced or restored to its normal anatomicposition, and generally normal to the force applied. The surface that isreduced or displaced defines the X-Y plane. This definition holds forother procedures performed with the invention.

Returning to the figure, the cavity 18 is typically ovaloid in shape asprojected in the X-Y plane. The ovaloid shape has an approximatelyuniform height in the Z direction. This “shape” is referred tothroughout the specification as a “transverse cavity” for the vertebralbody application illustrated in these figures. Therefore the X-Y planeis defined as the “transverse plane” and the Z-axis direction may bereferred to as the “vertical axis.” It is a characteristic of all theembodiments of the tools shown in the application that the crosssectional area of the tool at the entry point into the bone is smallerthan the transverse cavity created with the tool.

To facilitate description of the invention, the distal “working”structures of the cavity creation tools are illustrated in isolationwhile the proximal manipulation handles as contemplated are showngenerically as handle 20 and finger loop 21. In each embodiment, ahandle structure 20 can be moved with respect to the tool sheath or toolbody 14. In each embodiment, the relative motion between handle 20 andsheath 14 activates the distal working surfaces of the device. Thehandle 20 or the finger loop 21 is indexed to the distal workingsurfaces to provide confirmation of the orientation of the workingsurfaces with respect to the bone structures.

It is contemplated that in addition to direct manual manipulation, otherpower sources can be used to actuate the working surfaces, includinghydraulic or pneumatic cylinders and electromechanical actuators showngenerically in FIG. 1 as power source 23. In general, purely manualmechanical mechanisms are preferred because they improve tactilefeedback to the physician.

The tools may be made of conventional materials, with stainless steelpreferred for “blade” embodiments and Nitinol or other super elasticalloys adopted for the flexible arm embodiments. The tools may bereusable or disposable. Materials choices do not appear critical forcarrying out the invention.

The overall length of the cavity creation tool from the handlestructures 20 and 21 to the working distal tip may vary to facilitatethe particular surgical procedure. For example, a length of 220 cm isuseful for the vertebral application, while a length of 60 cm is apractical value for a tibial plateau procedure.

FIG. 2 shows an embodiment of the cavity creation tool 30 that includesa blade 38 mounted on the tool body 14 for rotational motion around thepivot 34. The rod 32 is coupled to a proximal handle 20 (FIG. 1) and apush-pull motion between the handle and the finger loop 21 (FIG. 1)causes the blade to sweep out an arc 40. The blade may be blunt or itmay include a cutting surface 42. In operation, the blade 38 laterallyloads cancellous bone, breaking or cutting the bone in the X-Y plane ofthe cavity. The pivot and blade are confined to a transverse plane sothis action creates the transverse cavity. By advancing the tool alongthe axis 36, the cavity may take an approximately oval shape in the X-Yplane.

FIG. 3 shows a cavity creation tool 62 having a distal end that ispositioned in a vertebral body. The distal end includes two arms. Afirst arm 52 is anchored to the tube 14 with a hinge point mechanism 56at a first end. The second end of the arm 52 is coupled to the pull rod64. Relative motion between the tube 14 and the pull rod 64 expands thefirst arm in a transverse plane. This particular embodiment of the toolis asymmetric and the tool includes a second arm 58 that is anchored tothe tube 14 with a hinge mechanism 60. The first and second arms definea plane for the operation of the device in the transverse plane.

FIG. 4 shows a cross section of the tool body 14 having a notch orgroove 15 for locating and restraining a pull rod 32. The tool bodycross section defines the tool body area for the cavity creation tool.In general, the tool may be inserted into a bone through a hole of thesize of the tool body area. This parameter or area is always smallerthan the “footprint” of the transverse cavity in the X-Y plane. Thecross section of this portion of the tool defines the tool body area.

FIG. 5 shows a pull rod 32 is constrained in a groove in the tool body14. In this embodiment the pull rod actuates a blade or other structure.The cross section of this portion of the tool defines the tool bodyarea.

FIG. 6 shows an embodiment of the tool that has two pull or push rods100 and 106. Pull rod 106 operates a first arm 108 while the second arm102 is activated by the independent pull rod 102. The asymmetricaloperation of the two independent arms can be used to control the shapeof the cavity by directing expansion of the cavity to preferred areaswithin the vertebral body.

FIG. 7 shows an embodiment of the tool 70 where a container 72 surroundsa pair of arms 52 and 58. The container interacts with the cancellousbone as the pull rod activates the arms and moves them against thecancellous bone. The container prevents debris from interfering with theretraction of the arms. The container 72 can be subsequently inflated toreduce the fracture and restore the natural anatomy. Finally, thecontainer may be detached and left behind.

In this particular embodiments the first and second arms are identical,and will normally create a symmetric cavity. The container 72 isoptional and the arms can be used alone in a fashion analogous to otherversions of the tool.

In this particular embodiment, the first and second arms have bluntdissection surfaces on the exterior of the arms to interact withcancellous bone. In this embodiment, the first and second arms may alsohave different mechanical properties for the creation of an asymmetriccavity.

FIG. 8 shows an embodiment of the cavity creation tool 80 that includessaw-like teeth on the first arm 88 and the second arm 82. Once again,traction on the pull rod 64 causes the teeth on the arms to cut throughthe cancellous bone. In a fashion similar to related embodiments, thearms lie in and define a cutting plane that creates a transverse cavity.The saw teeth typified by tooth 90 can be moved by manipulating both thepull rod and the tube.

FIG. 9 shows a cable-actuated device with a cable 200 wrapping a spindleor axle 202 mounted on the tool body 214. Cable motion results insweeping out an arc 210 as seen in FIG. 10.

FIG. 10 shows the blade 38 can sweep through 360 degrees because ofcable actuation. An arc of less than 360 degrees may be used when anon-circular cavity is required.

FIG. 11 is a cable-operated version with the pull rod 232 coupled tocable 200. In this device, the pull on the cable forces the flex arms202 and 208 in an outward direction to form the transverse cavity.

FIG. 12 shows the cable-operated version of FIG. 9 with the armsdeployed, creating a transverse cavity.

FIG. 13 which represents the prior art is a schematic of a balloon orother hydraulic lifting device as it is initially inserted into thevertebral body.

FIG. 14 is a schematic of the increased lifting force generated by aballoon or other hydraulic lifting device which immediately reaches abroad surface area because of the transverse cavity that has beenprepared before deploying the balloon or hydraulic lifting device.

Although the invention has been illustrated in one context, it should beapparent that the device features maybe modified or combined inalternate configurations.

1-8. (canceled)
 9. A tool for creating a cavity in a bone comprising: anelongated body having a distal end and having a proximal end, said bodyhaving an exterior diameter defining a tool body area for the tool; ashearing element anchored to said distal end of said body by an anchorelement; said anchor element and said distal end of said body togetherforming a hinge to permit and to restrict said shearing element to movesubstantially only in a transverse plane relative to said body; wherebythe motion of said shearing element in said transverse plane sweeps outa cutting arc, said cutting arc defining an area larger than saiddelivery area; an actuator located within said body and connected tosaid shearing element; and a handle attached to said actuator and havinga portion extending exteriorly of the proximal end of said body formanual manipulation of said actuator; whereby motion imparted to saidactuator rod moves said shearing element through said cutting arc. 10.The tool of claim 9 wherein said shearing element is a blade.
 11. Thetool of claim 9 wherein said blade is blunt.
 12. The tool of claim 9wherein said blade includes a cutting surface.
 13. The tool of claim 9wherein said actuator includes a push-pull element coupled between saidproximal end and said distal shearing element.
 14. The tool of claim 9wherein said actuator includes a cable pull element coupled between saidproximal end and said distal shearing element.
 15. The tool of claim 9wherein said handle is indexed relative to said shearing element so asto position said shearing element within said bone to a desiredorientation by the position of the handle.
 16. The tool of claim 15wherein said handle includes a finger loop.
 17. The tool of claim 9further including: an electrical solenoid to provide power to saidactuator.
 18. The tool of claim 17 further including: a high frequencyforcing function superimposed on the solenoid drive signal generating animpacting force to said actuator.
 19. The tool of claim 9 furtherincluding: a pneumatic cylinder to provide power to said actuator. 20.The tool of claim 19 further including: a high frequency forcingfunction superimposed on the pneumatic cylinder drive signal generatingan impacting force to said actuator.
 21. The tool of claim 9 furtherincluding: an electro mechanical actuator to provide power to saidactuator.
 22. The tool of claim 21 further including: a high frequencyforcing function superimposed on the electro mechanical actuator drivesignal generating an impacting force to said actuator.
 23. (canceled)24. The tool of claim 9 wherein said shearing element is a flexible bowelement.
 25. The tool of claim 24 wherein said flexible bow element hasa cross section that varies along its length.
 26. The tool of claim 24wherein said bow has a sharp exterior edge for shearing bone.
 27. Thetool of claim 24 wherein said bow has a set of sharp teeth members onsaid exterior edge for shearing bone.
 28. The tool of claim 24 whereinsaid bow element is blunt.
 29. The tool of claim 24 wherein said bowelement is connected to said body at the distal end of said body andsaid bow element is anchored to said actuator at the distal end of saidactuator; whereby relative motion of said actuator toward said distalend of said body forces said bow outwardly in said transverse cuttingplane.
 30. The tool of claim 24 wherein said flexible element is locatedwithin a cover, which moves to accommodate the motion through an arc.31. The tool of claim 24 wherein said flexible bow element has aproximal end and a distal end wherein said flexible element has aconstant mechanical strength from its distal end to its proximal end.32. The tool of claim 24 wherein said flexible element has a proximalend and a distal end and wherein said flexible element varies inmechanical strength from its distal end to its proximal end.
 33. Thetool of claim 24 wherein said flexible element has a proximal end and adistal end and wherein said flexible element is constant in crosssectional area from its distal end to its proximal end.
 34. (canceled)35. (canceled)
 36. (canceled)
 37. (canceled)
 38. (canceled)
 39. The toolof claim 9 wherein the shearing element is constructed of a superelasticmaterial.
 40. The tool of claim 9 further including a pair of saidshearing elements including a first shearing element and a secondshearing element each being anchored to said distal end of said body byan anchor element.
 41. The device of claim 40 wherein said shearingelements are flexible bow elements.
 42. The device of claim 41 whereinsaid bow elements have a sharp exterior edge for shearing bone.
 43. Thedevice of claim 41 wherein said bow elements have a set of sharp teethmembers on said exterior edge for shearing bone.
 44. The device of claim41 wherein said bow elements are blunt.
 45. A tool for use in treating avertebral compression fracture in a spine, comprising: an elongated bodyhaving a distal end and a proximal end; a movable element configured tobe placed into a fractured vertebra, said element supported by andmovable relative to said body at said distal end thereof substantiallyonly in a plane transverse to said body; an actuator supported by saidbody and operably coupled to said element to impart relative movementbetween said element and said body; and a handle attached to saidactuator and having a portion extending exteriorly of the proximal endof said body for manual manipulation of said actuator.
 46. The tool ofclaim 45, wherein said handle is indexed relative to said movableelement so as to position said movable element within said vertebra to adesired orientation by the position of the handle.
 47. The tool of claim45, wherein said handle comprises a finger loop.
 48. A tool for use intreating a vertebral compression fracture in a spine, comprising: anelongated body having a distal end and a proximal end; a movable elementsupported by and movable relative to said body at said distal endthereof and configured to be placed into a fractured vertebra and movesubstantially only in a plane transverse to said body; and a containersubstantially surrounding said element and attached to said body andconfigured to accommodate the movement of said element.
 49. The tool ofclaim 48, wherein said element comprises a flexible element configuredto swing outwardly in said transverse plane.
 50. The tool of claim 49,wherein said flexible element comprises two flexible arms configured toswing outwardly in opposite directions.
 51. The tool of claim 48,wherein said container is releasably attached to said body.
 52. The toolof claim 48, wherein said container is inflatable.
 53. The tool of claim52, wherein said container comprises a balloon.
 54. The tool of claim52, further including a bone filler material for introduction into saidcontainer.